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EU Regulator Approves AI Tool for Fatty Liver Disease Trials

/in /tarafından

The European Medicines Agency (EMA) has approved the use of an artificial intelligence (AI) tool, AIM-NASH, to assess the severity of metabolic dysfunction-associated steatohepatitis (MASH) in clinical trials. The condition, which affects 1.5% to 6.5% of U.S. adults, is a challenging liver disease with limited treatment options.

AIM-NASH utilizes machine learning trained on over 100,000 annotations from 59 pathologists who analyzed more than 5,000 liver biopsies across nine major clinical trials. The EMA’s human medicines committee (CHMP) found that the AI tool provides more consistent and reliable assessments than traditional methods, which rely on subjective evaluations from multiple pathologists.

With this approval, data generated using AIM-NASH will be considered scientifically valid in clinical trials, potentially accelerating the development of new MASH treatments. Currently, Madrigal Pharmaceuticals’ Rezdiffra is the only U.S.-approved drug for MASH, while companies like Novo Nordisk and Eli Lilly are conducting trials to explore additional treatment options.

EU to Review Novo Nordisk’s Ozempic Over Eye Disease Concerns

/in /tarafından

The European Medicines Agency (EMA) announced it would evaluate two recent Danish studies linking Novo Nordisk’s diabetes medication, Ozempic, to an increased risk of a rare eye disease known as non-arteritic anterior ischemic optic neuropathy (NAION).

The studies, published earlier this week, revealed that Ozempic could more than double the likelihood of patients with type 2 diabetes developing NAION. This condition, which can lead to sudden vision loss, occurs when blood flow to the optic nerve is reduced.

Previously, the EMA had reviewed other research but found no conclusive evidence connecting Ozempic to the rare eye disease. However, the agency stated late Tuesday that the findings from these new Danish studies may provide significant new information, prompting further investigation.

Ozempic, which is also widely prescribed for weight loss, has become one of Novo Nordisk’s most successful drugs, contributing to the company’s dominant position in the diabetes and obesity treatment market.

The EMA did not specify a timeline for the review but emphasized its commitment to ensuring the safety of all medications in the EU market.

 

EU to Review Novo Nordisk’s Ozempic Over Eye Disease Concerns

/in /tarafından

The European Medicines Agency (EMA) announced it would evaluate two recent Danish studies linking Novo Nordisk’s diabetes medication, Ozempic, to an increased risk of a rare eye disease known as non-arteritic anterior ischemic optic neuropathy (NAION).

The studies, published earlier this week, revealed that Ozempic could more than double the likelihood of patients with type 2 diabetes developing NAION. This condition, which can lead to sudden vision loss, occurs when blood flow to the optic nerve is reduced.

Previously, the EMA had reviewed other research but found no conclusive evidence connecting Ozempic to the rare eye disease. However, the agency stated late Tuesday that the findings from these new Danish studies may provide significant new information, prompting further investigation.

Ozempic, which is also widely prescribed for weight loss, has become one of Novo Nordisk’s most successful drugs, contributing to the company’s dominant position in the diabetes and obesity treatment market.

The EMA did not specify a timeline for the review but emphasized its commitment to ensuring the safety of all medications in the EU market.